FLUXERGY Reaction Mix COVID-19

Using state-of-the-art RT-PCR and microfluidic technology, the Fluxergy COVID-19 Test Kit has been shown to identify the SARS-CoV-2 virus within one hour. This device is intended for healthcare professionals only. The results were obtained from an internal performance evaluation using clinical samples compared with a method approved by the FDA-USA.

How To Run A Fluxergy PCR?

The Fluxergy COVID-19 test, using state-of-the-art PCR and microfluidic technology, has been shown to identify the SARS-CoV-2 virus within one hour. See how easy it is to run a PCR test in your lab with the Fluxergy compact analyzer.

Simple Sample Preparation

RNA extraction is NOT required. The Fluxergy COVID-19 Test Kit, which uses state-of-the-art RT-PCR and microfluidic technology for a simplified workflow. *

1. Thaw and centrifuge the reaction mix tube with a mini centrifuge.
2. Vortex the swab sample in VTM.
3. Pipette the sample into the reaction mix tube.
4. Gently rock the bottom of the tube 5 times and twist.
5. Place the Fluxergy card on a flat surface.
6. Carefully dispense the master mix onto the Fluxergy card.
7. Press the plastic cap onto the Fluxergy card.
8. Insert the Fluxergy card into the Fluxergy analyzer.
9. Click “OK” in Fluxergy Works to start the test.
10. The test will be complete in approximately 1 hour.

Assay Specifications

  • Test type: RT-PCR, direct
  • Time to obtain the result: ~ 55 minutes
  • Sample preparation: ~ 3 min from reagent thaw, no extraction required
  • Sample Type: NPS in 3 mL VTM, see accepted VTM *
  • Required sample volume: 14µL
  • Storage Condition: COVID-19 Fluxergy Card: 10 ° to 30 ° C COVID-19 Fluxergy Reaction Mix: -10 ° to -30 ° C
  • The gene targets: the Orf1ab polyprotein and the N gene; Detects B.1.351 and B.1.1.7. variants (no difference)
  • LOD * : 0.89 TCID50 / ml

Platform Specifications

Analyzer Size: 26.19 cm x 13.13 cm x 25.80 cm

Analyzer Weight: 6.8 kg

Power input: 12V DC, 7A

Operating temperature: 15 ° C – 30 ° C

Storage temperature: 15 ° C – 30 ° C

Operating humidity: 10% -85%

Minimum computer requirements:

  • Operating system: Operating system must be 64-bit, Windows 10 v1151
  • Processor: Intel Core i5 2.5GHz or equivalent Ram: 8GB DDR4 HDD: 250GB
  • Display: 1080p
  • USB: 2×2.0 port (for scanner and mouse)
  • Networks: Ethernet port

Data analysis tools: Interpretation of qualitative results, manual review of the amplification curve

Test Results

In a real-time PCR assay, positive detection of the target nucleic acid is confirmed by the accumulation of a fluorescent signal after the specific target DNA is amplified. The Fluxergy Works software will generate a qualitative positive or negative result from your PCR test. This is determined by sensors looking for amplification/presence of the target gene (solid line) and an internal control target (dashed line). The internal control objective monitors the integrity of the sample and the functionality of the system.

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